Anesthesiology
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- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- MQENeedle, Assisted Reproduction2Product Code
- MQFCatheter, Assisted Reproduction2Product Code
- K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)2Cleared 510(K)
- K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)2Cleared 510(K)
- K231730FemaSeed Intratubal Insemination2Cleared 510(K)
- K220010Daylily Single Use Sterile Embryo Transfer Catheter2Cleared 510(K)
- K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators2Cleared 510(K)
- K192540Kitazato ET Catheters2Cleared 510(K)
- K190522Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)2Cleared 510(K)
- K191015Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)2Cleared 510(K)
- K180302Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter2Cleared 510(K)
- K173431Towako Transmyometrial Embryo Transfer Set2Cleared 510(K)
- K173103Pivet and Soft-Pass Embryo Transfer Catheter Sets2Cleared 510(K)
- K173686Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter2Cleared 510(K)
- K172051Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter2Cleared 510(K)
- K172321Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters2Cleared 510(K)
- K163318Soules Intrauterine Insemination Catheter2Cleared 510(K)
- K162878Kitazato ET Catheters2Cleared 510(K)
- K162667Kitazato IUI Catheter2Cleared 510(K)
- K161547Transem and EchoGen Embryo Transfer Catheters2Cleared 510(K)
- K162064CrossBay IVF Embryo Transfer Catheter Set2Cleared 510(K)
- K143669MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter2Cleared 510(K)
- K141666FERTILIGENT SLOW RELEASE IUI CATHETER KIT2Cleared 510(K)
- K131491KITAZATO IUI CATHETER2Cleared 510(K)
- K112396IUI CATHETERS2Cleared 510(K)
- K120154INTRAUTERINE INSEMINATION (IUI) CATHETER2Cleared 510(K)
- K092579INTRAUTERINE INSEMINATION (IUI) CATHETER2Cleared 510(K)
- K053208CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET2Cleared 510(K)
- K052059IUI CATHETER, MODEL 90572Cleared 510(K)
- K050521EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S2Cleared 510(K)
- K041470MORTON IUI CATHETERS2Cleared 510(K)
- K033084WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER2Cleared 510(K)
- K023382COOPERSURGICAL MALLEABLE SYTLET2Cleared 510(K)
- K023383COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER2Cleared 510(K)
- K023384COOPERSURGICAL TRIAL TRANSFER CATHETER2Cleared 510(K)
- K023017TUCKER EMBRYO CATHETER2Cleared 510(K)
- K023379COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER2Cleared 510(K)
- K013536EMTRAC; DELPHIN; SEMTRAC 2000 SET2Cleared 510(K)
- K013501IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B2Cleared 510(K)
- K012220TAO EMBRYO TRANSFER CATHETER SYSTEM2Cleared 510(K)
- K000950EMBRYO TRANSFER CATHETER SET, MODEL 320200 AND 3202012Cleared 510(K)
- K000656EMBRYON GIFT TRANSFER CATHETERS/SETS2Cleared 510(K)
- K994327EMBRYON TRANSFER CATHETERS/SETS2Cleared 510(K)
- K992307EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER2Cleared 510(K)
- K991266<GENX> EMBRYO TRANSFER CATHETER CC GLIDER2Cleared 510(K)
- K990348WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N2Cleared 510(K)
- K990349WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST2Cleared 510(K)
- K990350WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 23162Cleared 510(K)
- K983604INTRA-UTERINE TRANSFER, INTRA-FOLOPIAN TRANSFER2Cleared 510(K)
- K983595TRANSMYOMETRIAL EMBRYO TRANSFER SET2Cleared 510(K)
- K983590GIFT CATHETER SET/S2Cleared 510(K)
- K983591INTRATUBAL TRANSFER SETS2Cleared 510(K)
- K983594EMBRYO TRANSFER CATHETERS/SETS2Cleared 510(K)
- K983587HYSTEROSCOPIC GIFT CATHETER SETS2Cleared 510(K)
- MQGAccessory, Assisted Reproduction2Product Code
- MQHMicrotools, Assisted Reproduction (Pipettes)2Product Code
- MQIMicrotool Fabrication, Assisted Reproduction2Product Code
- MQJMicromanipulators And Microinjectors, Assisted Reproduction2Product Code
- MQKLabware, Assisted Reproduction2Product Code
- MQLMedia, Reproductive2Product Code
- MRXSystem, Assisted Reproduction Laser2Product Code
- MTWSystem, Water, Reproduction, Assisted, And Purification2Product Code
- MTXMicroscope And Microscope Accessories, Reproduction, Assisted1Product Code
- NNBNeedle, Reproduction, Assisted, Reprocessed2Product Code
- PBHEmbryo Image Assessment System, Assisted Reproduction2Product Code
- OYOCulture, Intravaginal, Assisted Reproduction2Product Code
- PUBAccessory, Assisted Reproduction, Exempt2Product Code
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt2Product Code
- PUDLabware, Assisted Reproduction, Exempt2Product Code
- QKHAssisted Reproduction Laminar Flow Workstation2Product Code
- QKIMedia, Reproductive, Exempt2Product Code
- QUJAutomated Cryopreservation Storage System2Product Code
- QYZAt Home Intravaginal Insemination System2Product Code
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Transem and EchoGen Embryo Transfer Catheters
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K161547
- 510(k) Type
- Traditional
- Applicant
- Origio A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/9/2017
- Days to Decision
- 279 days
- Submission Type
- Summary